Rising Pharmaceuticals, Laurus Labs to Support a Phase 2 Randomized Clinical Trial of Hydroxychloroquine for Prophylaxis Against COVID-19 in Patients Receiving Cancer Therapy

7 May 2020 - - US-based Rising Pharma Holdings, Inc., operating as Rising Pharmaceuticals, has donated Hydroxychloroquine tablets in support of a Phase 2 randomised clinical trial exploring hydroxychloroquine as preventive treatment for coronavirus disease 2019 (COVID-19) in patients with cancer who are receiving radiation therapy, the company said.

The trial is being conducted at Memorial Sloan Kettering Cancer Center, a leader in cancer care. The randomised, placebo-controlled Phase 2 trial will enroll patients at least 18 years of age who are undergoing radiation therapy alone or in combination with chemotherapy.

Subjects will be randomised 1: 1 to prophylactic hydroxychloroquine or placebo. The primary endpoint is to compare the likelihood of symptomatic COVID-19 infection between the hydroxychloroquine and placebo groups.

Secondary objectives are the likelihood of severe COVID-19 between groups, and to evaluate acute toxicity associated with administration of hydroxychloroquine during radiation or chemoradiation.

Hydroxychloroquine is a medication used for the prevention and treatment of certain types of malaria, as well as rheumatoid arthritis, lupus, and porphyria cutanea tarda, and is currently being evaluated in a variety of settings for its potential ability to prevent SARS-CoV-2 infection and to treat COVID-19.

Rising Pharmaceuticals and Laurus Labs have agreed to donate Hydroxychloroquine tablets to support MSK's study.

Hydroxychloroquine sulfate tablets are indicated for the following; treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and for the treatment of acute and chronic rheumatoid arthritis in adults.